Single use lancet device

ABSTRACT

A single use lancet device having a housing, a lancet with a piercing tip movably disposed in the housing and structured to move between a cocked orientation and a piercing orientation, and a driving assembly structured to move the lancet into the piercing orientation. A retention member and an engagement hub are further provided and structured to be cooperatively engaged with one another upon the lancet being disposed in the cocked orientation so as to maintain the lancet in the cocked orientation until released by an actuation assembly. Specifically, the actuation assembly is structured to move between an actuated and an un-actuated orientation, movement into the actuated orientation releasing the retention member and the engagement hub from their cooperative engagement with one another and thereby result in movement of the lancet into the piercing orientation. The device also includes a restrictor assembly structured to substantially prevent the actuation assembly from moving out of the actuated orientation, thereby preventing re-firing of the lancet utilizing the actuation assembly.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a single use lancet device structuredto be conveniently and effectively utilized for various blood samplingprocedure, but which is also substantially safe, preventing re-firing ofthe device after it has been used, and thereby preventing and/orsubstantially minimizing inadvertent contamination of a patient and/orother personnel as a result of a used and potentially contaminatedlancet. Furthermore, the device is compact and easy to utilize in a costeffective and preferably fully disposable manner.

2. Description of the Related Art

Lancets are commonly utilized instruments which are employed both inhospitals and other medical facilities, as well as by privateindividuals, such as diabetics, in order to prick or pierce a patient'sskin, typically on a finger of a patient, thereby leading to thegeneration of a blood sample which can be collected for testing. Becauseof the wide spread use of such lancets, there are a variety of lancetdevices which are available for utilization by patients and/orpractitioners in a variety of different circumstances.

For example, a typical lancet may merely include a housing with a sharppiercing tip that is pushed into the patient's skin. More commonly,however, lancet devices, which house a piercing tip and/or a lancet,have been developed which effectively encase and fire the lancet intothe patient's skin, thereby eliminating the need for the person takingthe sample to actually push the lancet tip into the skin.

Within the various types of specialized lancet devices, one variety aretypically configured for multiple and/or repeated uses, while anothercategory is particularly configured for single use, after which theentire device is disposed of. Looking in particular to the single use,disposable lancet devices, such devices typically include a housingwhich contains and directs or drives a piercing tip into the patient'sskin, and which is disposed of along with the used lancet. Naturally, soto make such disposable devices cost effective for frequent use, suchdevices tend to be rather simplistic in nature providing only asufficient mechanism for firing, and not overly complicating the designso as to minimize that cost.

While existing single use devices are generally effective for achievingthe piercing of the skin required for effective operation, such singleuse, disposable devices typically do not incorporate a large number ofsafety features to ensure the safe use and disposal of the device. Forexample, one primary area of safety which must be addressed with alllancet devices pertains to the purposeful and/or inadvertent reuse of acontaminated lancet. Unfortunately, most currently available single uselancet devices are configured such that after a use thereof has beenachieved, it is possible for a patient to re-cock the device, therebyallowing for a subsequent, inappropriate use.

As a result, it would be highly beneficial to provide a single uselancet device which is substantially compact and disposable, can bemanufactured in a substantially cost effective manner, and whichnevertheless is substantially safe to utilize, affirmatively preventingre-use, once contaminated. Additionally, it is noted that while otherdevices may be provided to prevent the lancet form even being cocked, itwould still be beneficial to provide a device that even if the lancet isre-cocked does not allow for additional and/or secondary firing.

SUMMARY OF THE INVENTION

The present invention is direct to a single use lancet device of thetype commonly utilized for various blood sampling purposes. Inparticular, the single use lancet device of the present inventionincludes a housing and a lancet. The lancet, which also includes apiercing tip, is movably disposed in the housing and is structured tomove at least between a cocked orientation and a piercing orientation. Adrive assembly is provided so as to actually move the lancet at leasttemporarily into the piercing orientation.

In order to retain the lancet in the cocked orientation, the illustratedembodiment of the single use lancet device of the present inventionincludes a retention member and a engagement hub. In particular, theengagement hub is structured to be cooperatively engaged with theretention member, at least when the lancet is disposed in the cockedorientation. As a result, the retention member and the engagement hub,which are cooperatively engaged with the housing and the lancet,effectively maintain the lancet in the cocked orientation until they arereleased from that engagement with one another. As such, it is seen, inthis embodiment, that when the lancet is ready for use, it is maintainedin the cocked, ready to fire orientation until that time.

In order to release the lancet, and more particularly the cooperativeengagement between the retention member and the engagement hub of theillustrated embodiment, the present invention further includes anactuation assembly. Specifically the actuation assembly is structured tomove between an actuated and an un-actuated orientation. In this regard,movement of the actuation assembly into the actuated orientation isstructured to release at least the retention member and the engagementhub from their cooperative engagement with one another, therebyresulting in movement of the lancet into the piercing orientation.

In order to substantially minimize the inadvertent re-use of the singleuse lancet device of the present invention, a restrictor assembly isalso preferably provided. Specifically, the restrictor assembly isstructured to substantially prevent the actuation assembly from movingout of the actuated orientation, at least after the lancet has moved atleast temporarily into the piercing orientation. In this regard, therestrictor assembly may include an abutment structure that iscooperatively disposed between the housing and a release element of theactuation assembly that actually releases the retention member and theengagement hub from their cooperative engagement with one another. Assuch, once the lancet device of the present invention has been fired theactuation assembly cannot move back into its un-actuated orientation fora subsequent firing, regardless of whether the lancet itself may or maynot be moved back into the cocked orientation.

These and other features and advantages of the present invention willbecome more clear when the drawings as well as the detailed descriptionare taken into consideration.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature of the present invention,reference should be had to the following detailed description taken inconnection with the accompanying drawings in which:

FIG. 1 is a rear perspective illustration of the single use lancetdevice of the present invention;

FIG. 2 is a side cross-section view of an embodiment of the single uselancet device of the present invention illustrating the lancet in thecocked orientation, and the actuation assembly in the un-actuatedorientation;

FIG. 3 is a side cross-section view of the embodiment of FIG. 2illustrating the lancet temporarily disposed in the piercingorientation, and illustrating the actuation assembly disposed in theactuated orientation; and

FIG. 4 is a top plan view of the single use lancet device of the presentinvention illustrating an embodiment of the cocking assembly.

Like reference numerals refer to like parts throughout the several viewsof the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Shown throughout the Figures, the present invention is directed towardsa single use lancet device, generally indicated as 10. In particular,the lancet device 10 is utilized to help facilitate the taking of ablood sample, such as may be commonly performed by diabetics and/or bymedical personnel. In this regard, the single use lancet device isstructured to prick a portion of the patient's body, such as commonlythe finger, resulting in a small amount of bleeding which can becollected for sampling and subsequent testing.

Looking in particular to the single use lancet device 10 of the presentinvention, it includes a housing 20. The housing 20 is preferablygenerally in small and compact in shape so as to facilitate manipulationand grasping by a user. Furthermore, the housing 20 may be constructedfrom any of a variety of materials, although plastic may be the mostcommonly used material for ease in manufacture and/or costeffectiveness. The housing 20 includes an open interior 22, and at leasta piercing opening 26. The piercing opening 26 provides access to theopening interior 22, such as at an end of the housing 20.

Contained at least partially within the open interior 22 of the housing20 is a lancet 30. Specifically, the lancet 30 includes a piercing tip32 which will actually and ultimately emerge from the housing 20 andresult in the piercing of the patients skin for the required bleeding.In this regard, the present invention is described in the context of asingle use lancet device 10, and preferably a fully disposable singleuse lancet device 10. As such, the lancet 30 in the illustratedembodiment is preferably a self contained and generally integral elementwithin the housing 20, perhaps including a separate metal piercingshaft. It is of course, understood, however, that as is the case withmany re-useable lancet devices, it is possible for a more elaboratelancet assembly to be provided within the primary housing 20, the lancet30, which in includes the piercing tip 32, being disposed within acorresponding receiving assembly and moving therewith within the primaryhousing 20. As such, one or a plurality of components may indeedultimately comprise the lancet 30, although a single integral device isdisclosed with regard to the illustrated embodiment.

As indicated, the lancet 30 is structured to move within the housing 20and is structured to move at least from a cocked orientation, asillustrated in FIG. 2, to a piercing orientation, as illustrated in FIG.3. The cocked orientation of FIG. 2 is characterized generally by thelancet 30 being withdrawn within the housing 20, and being ready to befired. Conversely, the piercing orientation, as in FIG. 3, ischaracterize generally by the piercing tip 32 of the lancet 30protruding at least partially from the piercing opening 26 of thehousing 20. In this regard, and for safety purposes it is preferred thatthe piercing orientation of FIG. 3 be only temporarily maintained toachieve piercing of the finger, and that the normal movement of thelancet 30 result in its eventually residing in a retracted, although notcocked orientation concealed within the housing 20. Also along theselines, it is recognized that the lancet 30 may be provided initially tousers in a pre-cocked orientation, or as in the illustrated embodiment,may be provided in a retracted or concealed orientation which allows forthe ultimate user to actually move the lancet 30 into the cockedorientation prior to actual use. In all such instances of movement, itis recognized as illustrated in the Figures, that the lancet 30, ifdesired may include one or more protrusions 34 defined thereon so as tohelp to guide a generally straight and/or linear path of movement of thelancet 30. Of course, such structure is not necessarily required.

As seen in FIG. 4, a protective shields 78 may also preferably bepositioned over the piercing tip 32 of the lancet 30 prior to ultimateuse of the single use lancet device 10 of the present invention.Naturally, this protective guard 78, which may be separately orintegrally formed with the remainder of the lancet 30, is preferablydisposed in concealing relation to the piercing tip, and when the lancet30 is moved into the cocked orientation is removed, thereby exposing thepiercing tip for use. Although it is possible that the protective shield78 may be maintained on the piercing tip 32 even when the lancet 30 isin the cocked orientation, in the illustrated embodiment, the protectiveshield 78 preferably includes a generally large head such that when thelancet 30 is moved into the cocked orientation, the protective shield 78tends to be removed, either on its own, or with only a small degree ofassistance by the user. Certainly, more affirmative removal may also berequired.

In order to move the lancet 30 into the aforementioned cockedorientation, a cocking assembly 70 is provided. In particular, thecocking assembly 70 includes a cocking element 71 that is structured tobe manipulated by a user. Specifically, the cocking element 71preferably protrudes from the housing 70 and may, if desired, slidealong at least a portion of the length of the housing 20, such as withinone or more tracks 72. Moreover, as in the illustrated embodiment, agenerally sloped and potentially notched configuration may be providedfor the cocking element 71 so as to facilitate manipulation by a user inan effective and convenient manner. As best seen in FIGS. 2 and 3, thecocking element 71 preferably extends from within the housing 20,protruding to the exterior for manipulation by the user. In protrudingfrom the housing 20, however, the cocking element 71 also includes aninwardly depending abutment 74. Specifically, the inwardly dependingabutment 74 is preferably structured to engage the lancet 30 and may bestructured to engage a corresponding protrusion 36 on the lancet 30. Assuch, at least upon rearward movement of the cocking element 71, thelancet 30 is also moved backwards to a cocked orientation. Further, itis recognized that the cocking element 71 may be integral with thelancet 30 and/or may be a separate component, as in the illustratedFigures.

Looking now in further detail to the positioning of the lancet 30 in thecocked orientation of FIG. 2, as indicated, it is preferred that thelancet 30 will be disposed and generally held in that cocked orientationuntil affirmatively released, as will be described. In the illustratedembodiment, the present invention includes a retention member and anengagement hub that are cooperatively engaged with one another when thelancet 30 is disposed in the cocked orientation so as to maintain thelancet 30 in the cocked orientation until released. Also in theillustrated embodiment, the retention member includes at least onefinger 50 that extends from and/or may be integrally formed with theremainder of the lancet 30. Conversely, the engagement hub 44 is definedin connection with the housing 20 and is preferably a rigid, cooperativestructure. In this regard, the one and preferably two fingers 50 of theillustrated retention member preferably include a generally biasedconfiguration structured to somewhat compress and thereby allow passagethrough an opening defined by the engagement hub 44. Once the tips ofthe fingers 50 have passed beyond the engagement hub 44, a dependingprotrusion 52, that is preferably disposed on each of the fingers 50,may abut the engagement hub 44 thereby preventing passage of the lancet30 out of the cocked orientation until released.

The present single use lancet device 10 includes a drive assembly,generally indicated as 40. In the illustrated embodiment, the driveassembly 40 includes a biasing element 42, such as a spring, whichengages an appropriate surface in the primary housing 20. Also in theillustrated embodiment, the engagement hub 44 also acts as the abutmentsurface for the spring 42. As such, when the lancet 30 is moved towardsand into the cocked orientation, a compression of the biasing element 42results. Moreover, because the finger(s) 50 preferably includes agenerally sloped or tapered tip configuration, it is urged towards andinto the opening in the engagement hub 44, the finger(s) 50 generallycompressing towards the center of the housing for effective passagebeyond the engagement hub 44. Once the finger(s) 50 have passed asufficient distance, the finger(s) 50 will flair outwardly generallytowards there normal position and the depending protrusion 52 will abutthe engagement hub 44. Accordingly, despite the compressed tension ofthe biasing element 42, the tip of the fingers 50 are held from theengagement hub 44 by the depending protrusions 52.

In order to provide for the effective release of the lancet 30 from itscocked orientation, the present invention further includes an actuationassembly 60. Specifically, the actuation assembly 60 is structured to bemanipulated and/or actuated by a user in order to effectively releasethe lancet 30 from its cocked orientation. In this regard, the actuationassembly 60 is structured to move between an un-actuated orientation asin FIG. 2, to an actuated orientation, as in FIG. 3. The actuationassembly 60 includes an exterior or head portion, which is structured tobe effectively manipulated, and in particular pushed, by the user.Further, the actuation assembly 60 includes an interior release element62 that extends into the housing. The release element(s) 62 of theactuation assembly 60 preferably includes a generally stiff, but stillat least slightly biased configuration, and a gap 63 defined thereby.Specifically, the gap 63 is disposed such that the tip of the fingers 50of the retention member may pass therein as the actuation assembly 60 ismoved into its actuated orientation. In particular, the release elements62 are structured and disposed such that corresponding surfaces thereofengage the tips of the fingers 50. Furthermore, as the actuationassembly 60 is moved inwardly towards the actuated orientation, thestructure of the release elements 62 tend to compress the tips of thefingers 50. Finally, when actuation assembly 60 generally reaches itsactuated orientation, the fingers 50 are pressed sufficiently towardsone another, and in the case of only one finger, inwardly, such that thedepending protrusions 52 no longer abut the engagement hub 44, and thelancet 30 is released from the cocked orientation. At this point, thetension that has been maintained in the biasing element 42 drives thelancet 30 and in particular the piercing tip 32 through the piercingopening 26 to effectuate the prick of the patient.

As previously indicated, a concern associated with the utilization oflancet devices relates to the re-use of contaminated and/or usedlancets. As such, the present invention further includes a restrictorassembly. The restrictor assembly is structured to substantially preventthe actuation assembly 60 from moving out of its actuated orientation,as in FIG. 3, at least after the lancet 30 has moved into the piercingorientation, if only for a temporary period of time. Moreover, and moreprecisely, the restrictor assembly of the illustrated embodiment ensuresthat once the actuation assembly 60 has moved into actuated orientation,it cannot return to the un-actuated orientation under normalcircumstances. For example, the restrictor assembly preferably includesan abutment structure that is cooperatively disposed between the housing20 and the release element 62 of the actuation assembly 60. In thisregard, it is abutment structure that affirmatively prevents theactuation assembly 60 from moving back into the un-actuated orientationafter movement into the actuated orientation. Specifically, once thesingle use lancet device 10 of the present invention has been fired bymanipulation of the actuation assembly 60, even if a user wishes to cockthe lancet 30 towards, and even possibly into, the cocked orientation,the actuation assembly 60 can no longer function to release the lancet30 from that cocked orientation and result in a subsequent firing of thelancet 30. As such, only a single triggering of the actuation assembly60 can be achieved, and only a single firing of the single use lancetdevice 10 of the present invention can be provided.

Looking in greater detail to the abutment structure of the restrictorassembly, in the illustrated embodiment, it includes a shoulder elementand a restrictor panel. Furthermore, in the illustrated embodiment theshoulder element 64 is provided on each of the one or more releaseelements 62, and the restrictor panel 66 is defined in association withthe housing 20. Looking first to the positioning of the actuationassembly 60 in an un-actuated orientation, as in FIG. 2, the shoulderelement 64 of the release element 62 is disposed in such a position thatit is not engaged with the restrictor panel 66. Although the shoulderelement 62 may be disposed in a variety of orientations, in theillustrated embodiment, for convenient and stability of use, theshoulder element 64 is disposed within one or more correspondingrecesses 68 defined in the housing 20 when the actuating assembly 60 isdisposed in the un-actuated orientation. Further, these recesses 68 mayinclude an at least partially tapered configuration that may correspondto a similar configuration on the release elements 62 so as to define amating and/or tapered orientation between the release element 62 and theretention panel 66. Accordingly, and based on the partially biasedconfiguration of the release element(s) 62, as the actuation assembly 60is pushed inwardly towards it actuated orientation, the confrontingsloped surfaces and/or a single sloped surface, result in a generalcompression of the release element 62 towards a central axis, allowingfor the free movement of the actuation assembly 60 inwardly and into theactuated orientation. It is also seen in some embodiments that thiscompression may further facilitate the release of the lancet 30 from thecocked orientation.

Once the actuation assembly 60 has moved into the actuated orientation,as in FIG. 3, preferably at least due to the tendency of the releaseelement(s) 62 to spread generally outward, the shoulder element 64 abutsthe retention panel 66 and outward passage and/or movement of theactuation assembly 60 back into the un-actuated orientation cannotresult. Indeed, even if the lancet 30 were moved back into the cockedorientation and/or into engaging relation with actuation assembly 60,and in particular the release element 62, such would merely serve tofurther expand the releasing element(s) 62 and would not function toachieve a compression necessary to allow for removal of the actuationassembly 60 into the un-actuated orientation. Accordingly, once theactuation assembly 60 has been used to fire the single use lancet device10, it cannot be used again to achieve subsequent firing. Of course, itis recognized that a variety of other configurations may be provided forthe restrictor assembly so as to allow the actuation assembly 60 toeffectively move into the actuated orientation, performing its task ofreleasing the lancet 30 from its cocked orientation, but not allowingthe actuation assembly 60 to subsequently return to the un-actuatedorientation. Also, it is recognized that although it is generally notpreferred for the aforementioned reasons, some structure to release theactuation assembly 60 may be provided so as to allow it to move backinto the un-actuated orientation, such as in the case of inadvertenttriggering without the lancet 30 having been in the cocked orientation.

Since many modifications, variations and changes in detail can be madeto the described preferred embodiment of the invention, it is intendedthat all matters in the foregoing description and shown in theaccompanying drawings be interpreted as illustrative and not in alimiting sense. Thus, the scope of the invention should be determined bythe appended claims and their legal equivalents.

Now that the invention has been described,

What is claimed is:
 1. A single use lancet device comprising: a) ahousing; b) a lancet, said lancet including a piercing tip; c) saidlancet movably disposed in said housing and structured to move at leastbetween a cocked orientation and a piercing orientation; d) a drivingassembly structured to move said lancet at least temporarily into saidpiercing orientation; e) an actuation assembly structured to movebetween an actuated and an un-actuated orientation, movement of saidactuation assembly into said actuated orientation resulting in saidmovement of said lancet into said piercing orientation; and f) arestrictor assembly structured to substantially prevent said actuationassembly from moving out of said actuated orientation at least aftersaid lancet has moved at least temporarily into said piercingorientation by said drive assembly.
 2. The single use lancet devicerecited in claim 1 further comprising a retention member; and anengagement hub, said engagement hub structured to be cooperativelyengaged with said retention member at least upon said lancet beingdisposed in said cocked orientation so as to maintain said lancet insaid cocked orientation until said retention member is affirmativelyreleased from said cooperative engagement therewith.
 3. The single uselancet device recited in claim 2 wherein said actuation assembly isstructured and disposed to release said retention member from saidcooperative engagement with said engagement hub.
 4. The single uselancet device recited in claim 3 wherein said retention member includesat least one finger, said finger including a depending protrusionstructured to engage cooperative structure on said engagement hub whensaid lancet is disposed in said cocked orientation, said actuationassembly being structured to at least temporarily urge said finger outof said engagement with said cooperative structure on said engagementhub.
 5. The single use lancet device recited in claim 1 furthercomprising a cocking assembly, said cocking assembly being operativelyassociated with said lancet and structured to move said lancet into saidcocked orientation.
 6. The single use lancet device recited in claim 5wherein said cocking assembly is structured to protrude from saidhousing.
 7. The single use lancet device recited in claim 5 wherein saidcocking assembly is integrally formed with said lancet.
 8. The singleuse lancet device recited in claim 5 wherein said cocking assemblyincludes a cocking element structured to extend into said housing andinto movement engagement with said lancet.
 9. The single use lancetdevice recited in claim 8 wherein said cocking element protrudes from aside of said housing so as to facilitate movement by a user's finger.10. The single use lancet device recited in claim 1 wherein said lancetis structured to be maintained in said cocked orientation until releasedby said actuation assembly.
 11. The single use lancet device recited inclaim 10 wherein said actuation assembly includes a release elementstructured to release said lancet from said cocked orientation.
 12. Thesingle use lancet device recited in claim 11 wherein said restrictorassembly includes an abutment structure cooperatively disposed betweensaid housing and said release element, and structured to prevent saidactuation assembly from moving into said un-actuated orientation aftermovement into said actuated orientation.
 13. The single use lancetdevice recited in claim 12 wherein said abutment structure comprises ashoulder element and a restrictor panel, said restrictor panel and saidshoulder element structured to pass one another upon said actuationassembly moving from said un-actuated orientation to said actuatedorientation, and to abut one another upon attempted movement of saidactuation assembly into said un-actuated orientation after movement intosaid actuated orientation.
 14. The single use lancet device recited inclaim 13 wherein said shoulder element includes an at least partiallybiased configuration structured to at least partially retract tofacilitate passage of said restrictor panel and said shoulder elementpast one another in a first direction corresponding movement of saidactuation assembly into said actuated orientation from said un-actuatedorientation, and to expand subsequent said passage past one another insaid first direction such that said shoulder element and said restrictorpanel abut one another upon movement towards one another in a seconddirection generally opposite said first direction.
 15. The single uselancet device recited in claim 13 wherein said shoulder element isdefined on said release element of said actuation assembly lancet, andsaid restrictor panel is defined in said housing.
 16. The single uselancet device recited in claim 1 wherein said driving assembly includesa biasing element operatively disposed between said lancet and saidhousing.
 17. The single use lancet device recited in claim 16 whereinsaid biasing element comprises a spring.
 18. A single use lancet devicecomprising: a) a housing; b) a lancet, said lancet including a piercingtip; c) said lancet movably disposed in said housing and structured tomove at least between a cocked orientation and a piercing orientation;d) a driving assembly structured to move said lancet at leasttemporarily into said piercing orientation; e) a retention member and anengagement hub, said engagement hub structured to be cooperativelyengaged with said retention member at least upon said lancet beingdisposed in said cocked orientation so as to maintain said lancet insaid cocked orientation until said retention member and said engagementhub are released from said cooperative engagement with one another; f)an actuation assembly structured to move between an actuated and anun-actuated orientation, movement of said actuation assembly into saidactuated orientation structured to release said retention member andsaid engagement hub from said cooperative engagement with one anotherand thereby result in movement of said lancet into said piercingorientation; g) a restrictor assembly structured to substantiallyprevent said actuation assembly from moving out of said actuatedorientation at least after said lancet has moved at least temporarilyinto said piercing orientation; and h) said restrictor assembly includesan abutment structure cooperatively disposed between said housing andsaid actuation assembly, and structured to prevent said actuationassembly from moving into said un-actuated orientation after movementinto said actuated orientation.